AzTrials
AzTrials

Anemia in Chronic Kidney DiseasesPhase 1NCT04893187

A Phase 1 Study of SSS17 in Healthy Subjects.

A Phase 1 study testing SSS17 in people with Anemia in Chronic Kidney Diseases, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study will investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of single oral administration of 5 mg, 15 mg, 20 mg and 25 mg of SSS17 compared with placebo, and evaluate the efficacy, safety, tolerance, pharmacokinetics and pharmacodynamics of multiple oral administration of 15 mg and 20 mg of… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Anemia in Chronic Kidney Diseases
What is being tested?
SSS17
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
1 siteChina
Study dates
26 Jul 2021to 30 Jun 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Chinese healthy adult subjects aged 18-45 years (including the boundary value) at the time of signing the informed consent were male and female;
  • In the screening period, the weight of male subjects was more than or equal to 50.0 kg; Female weight ≥ 45.0 kg; Body mass index (BMI) ranged from 19.0 kg / m2 to 26.0 kg / m2 (including boundary value); BMI = weight kg / height m2);
  • Within 6 months from the date of signing the informed consent to the end of the trial, female subjects agreed to take reliable measures to avoid pregnancy and ensure no birth plan, while male subjects agreed to take reliable measures to avoid pregnancy and ensure no birth plan;
  • Willing to participate in the study and sign a written informed consent, able to communicate well with the researchers, and agreed to follow the requirements of the trial protocol and follow-up on schedule.

Who cannot join

  • Participated in other drug clinical trials within 3 months before screening;
  • Have any clinical history of serious diseases or are suffering from related diseases, including but not limited to digestive system (such as diarrhea, vomiting, inflammatory bowel disease, hemorrhoids, acute gastritis, peptic ulcer, acute and chronic gastrointestinal disorders with obvious digestive and absorption disorders), cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, gastrointestinal tract diseases, etc Diseases of nervous and mental system, blood system, immune system, etc; A history of any disease or thrombotic disease or vascular malformation that increases the risk of bleeding; Patients with dysphagia;
  • Allergic constitution, known allergic to test drug ingredients or allergic history to any drug or food (mango, shrimp, crab, lobster, etc.) or pollen allergy history;
  • Those who smoke more than 5 cigarettes / day or the same amount of tobacco after inquiry, or who can not ban smoking during the trial period; Or alcohol consumption per week is equal to 14 units (1 units 25mL wine Baijiu / 100mL wine / 285mL beer), or those who can not prohibit alcohol during the test period;
  • Have a history of drug abuse or drug abuse;
  • Within 6 months, there were fertility planning, sperm donation and egg donation planning;
Show all 18Show fewer
  • Patients with lactose intolerance (those who have had diarrhea after drinking milk);
  • Those who have special requirements for diet and cannot accept unified diet;
  • Blood donors or massive blood loss (≥ 400ml), EPO treatment, blood transfusion or use of blood products within 3 months before screening;
  • Those vaccinated within 8 weeks before screening or during the study period;
  • There was a history of acupuncture and blood sickness; Or with orthostatic hypotension;
  • Those who have participated in and used the trial drug;Those who have used any prescription drug, over-the-counter drug, Chinese herbal medicine, vitamins or health care products within 14 days before screening and whose time is less than 5 half-life of the drug or less than 2 weeks (whichever is the longest);
  • The serum pregnancy test of lactating and pregnant women, or female volunteers of childbearing age was positive;
  • The results of physical examination, chest X-ray, color Doppler ultrasound, electrocardiogram and laboratory examination were abnormal and clinically significant; Or hemoglobin of male subjects was more than 175.0 g / L; Or hemoglobin of female subjects was more than 150.0 g / L; Or hemoglobin of male and female were less than 113g / L;
  • Within 48 hours before enrollment, those who took any special diet that affected the absorption, distribution, metabolism and excretion of drugs, including pitaya, mango, grapefruit, lime, carambola or food or drink prepared from them, chocolate, and any food or drink containing caffeine;
  • Urine drug screening test was positive;
  • Alcohol breath test was positive within 24 hours before administration;
  • The researchers think that there are other cases that are not suitable for the trial.

Trial locations and contacts

1 site in 1 country.

Director Li contact

18028886429

747560265@qq.com

Professor Fang, Ph.D contact

13701165926

fygk7000@163.com

China1 site, 1 recruiting

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510700

    Yi Fang, Ph.D, 13701165926, fygk7000@163.com

    Yongmei Li, Ph.D, 13640691018, Liyongmei_gz@126.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 1 Study to Evaluate the Tolerance, Safety, Pharmacokinetics and Pharmacodynamics of Oral Administration of SSS17 in Chinese Healthy Adult Subjects With Single and Multiple Dose Escalation and the Effect of Food on the Pharmacokinetics of SSS17.

This study will investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of single oral administration of 5 mg, 15 mg, 20 mg and 25 mg of SSS17 compared with placebo, and evaluate the efficacy, safety, tolerance, pharmacokinetics and pharmacodynamics of multiple oral administration of 15 mg and 20 mg of SSS17 compared with placebo. In addition, the study will assess the effect of food on the pharmacokinetics of SSS17.

Read the detailed description

The study will enroll healthy volunteers from a single academic medical center in China. All participants will be informed about the study and potential risks and required to provide written informed consent prior to undergoing study-related procedures.The study will be divided into 3 parts.

Part 1: Subjects will be allocated 2:8 to receive placebo or SSS17（it was only 2:2 in 5mg dose group）,which will be administered by oral route with single dose. At each dose, tolerability, safety, PK and PD characteristics will be investigated.

Part 2: Subjects will be allocated 2:8 to receive placebo or SSS17, which will be administered by oral route with multiple dose. At each cohort，tolerability, safety, PK and PD characteristics will be investigated.

Part 3: The subjects will receive two cycles of treatment, one is given on an empty stomach, the other is given after a high-fat meal, with an interval of 15 days.

Being tested
SSS17, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SSS17Drug

    SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.

  • PlaceboDrug

    Matched placebo.

Study groups in NCT04893187
Study groupRoleWhat they receive
Part 1: Single Dose Escalation SSS17ExperimentalEscalating doses of SSS17, single dose administration
Receives: Drug: SSS17
Part 1: Single Dose Escalation matching PlaceboPlacebo comparatorEscalating doses of matching placebo, single dose administration
Receives: Drug: Placebo
Part 2: Multiple Dose Escalation SSS17ExperimentalEscalating doses of SSS17, multiple dose administration
Receives: Drug: SSS17
Part 2: Multiple Dose Escalation matching PlaceboPlacebo comparatorEscalating doses of matching placebo, multiple dose administration
Receives: Drug: Placebo
Part 3: Treatment Sequence 1 (A to B)ExperimentalThe subjects in the first cycle received oral administration of SSS17 on an empty stomach, and subjects in the second cycle received oral administration of SSS17 after a high-fat meal
Receives: Drug: SSS17
Part 3: Treatment Sequence 2 (B to A)ExperimentalThe subjects in the first cycle received oral administration of SSS17 after a high-fat meal, and the subjects in the second cycle received oral administration of SSS17 on an empty stomach
Receives: Drug: SSS17

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: AEs

    Assessment AEs by frequency and severity in the part 1

    Measured: Baseline up to Days 15

  2. Part 1: Maximum plasma concentration (Cmax) of SSS17

    Plasma samples will be collected and Cmax will be assessed in the part 1

    Measured: Up to 336 hours post-dose

  3. Part 1: Area under the concentration-time curve (AUC) of plasma concentration of SSS17

    Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 1

    Measured: Up to 336 hours post-dose

  4. Part 1: Time-to-Cmax (Tmax) of SSS 17

    Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 1

    Measured: Up to 336 hours post-dose

  5. Part 1: Elimination terminal half-life (t1/2) of SSS17

    Plasma samples will be collected and the t1/2 will be assessed in the part 1

    Measured: Up to 336 hours post-dose

  6. Part 1: . Total amount of SSS17 excreted in urine over 72 hours (Ae0-72)

    Urine sample will be collected at pre-specified intervals and Ae0-72 will be assessed in the part 1

    Measured: Up to 72 hours post-dose

  7. Part 1: Fraction of SSS17 excretion during each collection interval (Fe0-72)

    Urine sample will be collected at pre-specified intervals and Fe0-72 will be assessed in the part 1

    Measured: Up to 72 hours post-dose

  8. Part 1: Renal clearance (CLR) of SSS17

    Urine sample will be collected at pre-specified intervals and CLR will be assessed in the part 1

    Measured: Up to 72 hours post-dose

  9. Part 2: AEs

    Assessment AEs by frequency and severity in the part 2

    Measured: Up to Days 33 or 57

  10. Part 2: Steady state minimal concentration (Css_min) of SSS17

    Plasma samples will be collected and Css_min will be assessed in the part 2

    Measured: Up to Days 33 or 57

  11. Part 2: Steady state maximum concentration (Css_max) of SSS17

    Plasma samples will be collected and Css_max will be assessed in the part 2

    Measured: Up to Days 33 or 57

  12. Part 2: Steady state average concentration (Css_av) of SSS17

    Plasma samples will be collected and Css_av will be assessed in the part 2

    Measured: Up to Days 33 or 57

  13. Part 2: Area under the concentration-time curve of plasma concentration of SSS17 within the interval of administration after reaching steady state (AUC0-τ)

    Plasma samples will be collected and the AUC from zero to τ will be assessed

    Measured: Up to Days 33 or 57

  14. Part 3: Maximum plasma concentration (Cmax) of SSS17

    Plasma samples will be collected and Cmax will be assessed in the part 3

    Measured: Up to Days 44

  15. Part 3: Area under the concentration-time curve (AUC) of plasma concentration of SSS17

    Plasma samples will be collected and the AUC from zero to infinity will be assessed in the part 3

    Measured: Up to Days 44

  16. Part 3: Time-to-Cmax (Tmax) of SSS 17

    Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve in the part 3

    Measured: Up to Days 44

  17. Part 3: Elimination terminal half-life (t1/2) of SSS17

    Plasma samples will be collected and the t1/2 will be assessed in the part 3

    Measured: Up to Days 44

Secondary outcomes (19)

  1. Part 1: EPO concentrations

    Change of EPO concentrations from baseline following SSS17 in the part 1

    Measured: Up to 168 hours post-dose

  2. Part 1: VEGF concentrations

    Change of VEGF concentrations from baseline following SSS17 in the part 1

    Measured: Up to 168 hours post-dose

  3. Part 1: Change of hepcidin from baseline

    Change of serum hepcidin concentrations from baseline following SSS17 in the part 1

    Measured: Up to 168 hours post-dose

  4. Part 1: Change of RTC from baseline

    Change of RTC from baseline following SSS17 in the part 1

    Measured: Baseline up to Days 15

  5. Part 1: Change of RBC from baseline

    Change of RBC from baseline following SSS17 in the part 1

    Measured: Baseline up to Days 15

  6. Part 1: Change of Hgb from baseline

    Change of Hgb from baseline following SSS17 in the part 1

    Measured: Baseline up to Days 15

  7. Part 2: EPO concentrations

    Change of EPO concentrations from baseline following SSS17 in the part 2

    Measured: Up to Days 33 or 57

  8. Part 2: VEGF concentrations

    Change of VEGF concentrations from baseline following SSS17 in the part 2

    Measured: Up to Days 33 or 57

  9. Part 2: Change of hepcidin from baseline

    Change of serum hepcidin concentrations from baseline following SSS17 in the part 2

    Measured: Up to Days 33 or 57

  10. Part 2: Change of RTC from baseline

    Change of RTC from baseline following SSS17 in the part 2

    Measured: Baseline up to Days 33 or 57

  11. Part 2: Change of RBC from baseline

    Change of RBC from baseline following SSS17 in the part 2

    Measured: Baseline up to Days 33 or 57

  12. Part 2: Change of Hgb from baseline

    Change of Hgb from baseline following SSS17 in the part 2

    Measured: Baseline up to Days 33 or 57

  13. Part 3: AEs

    Assessment AEs by frequency and severity in the part 3

    Measured: Up to Days 44

  14. Part 3: EPO concentrations

    Change of EPO concentrations from baseline following SSS17 in the part 3

    Measured: Up to Days 44

  15. Part 3: VEGF concentrations

    Change of VEGF concentrations from baseline following SSS17 in the part 3

    Measured: Up to Days 44

  16. Part 3: Change of hepcidin from baseline

    Change of serum hepcidin concentrations from baseline following SSS17 in the part 3

    Measured: Up to Days 44

  17. Part 3: Change of RTC from baseline

    Change of RTC from baseline following SSS17 in the part 3

    Measured: Baseline up to Days 44

  18. Part 3: Change of RBC from baseline

    Change of RBC from baseline following SSS17 in the part 3

    Measured: Baseline up to Days 44

  19. Part 3: Change of Hgb from baseline

    Change of Hgb from baseline following SSS17 in the part 3

    Measured: Baseline up to Days 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2021
  2. Study start26 Jul 2021
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04893187
Sponsor's protocol ID
SYSS-SSS17-UND-I-02
Status last verified
Dec 2021
First submitted
17 May 2021
Last updated
13 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SSS17 in people with Anemia in Chronic Kidney Diseases, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Director Li (18028886429, 747560265@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: AEs (time frame: Baseline up to Days 15). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04893187.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in